Manufacturers selling health IT into the NHS need a DCB0129 clinical safety case, and NHS organisations need DCB0160 assurance before they deploy. I act as your named CSO, from the first conversation about your product to safety sign-off and beyond.
Who it's for
The work is similar on both sides of the table. I've done it as a manufacturer's CSO and as the NHS buyer assessing products for GP practices.
DCB0129 · Clinical risk management in manufacturing
You're selling into the NHS and a customer, a DTAC assessment or a procurement process has asked for your clinical safety case, or you'd rather have it in place before they do. You need a named CSO who can stand behind it.
DCB0160 · Clinical risk management in deployment
ICBs, trusts, GP federations, PCNs and practices deploying tools such as AI scribes, digital front doors, AI receptionists or document management, who need a CSO to assess and sign off the deployment.
How it works
Every project follows the same core process, scaled to the size and clinical risk of the product.
A detailed discussion of how the product works, who uses it, where it sits in the clinical workflow, and where things could go wrong for patients.
Policies, regulatory position, quality assurance and any existing safety documentation, so the safety case reflects how the product is actually built, deployed and supported.
A structured session with your clinical, product and technical people to identify hazards, their causes and the controls that reduce the risk.
The clinical safety documentation the standard requires, including the clinical risk management plan, hazard log and clinical safety case report, signed off by me as your CSO.
Safety assessment of new features and changes, and regular review of the hazard log, so your safety case stays current as the product develops.
Good to know
Typically one to two months from signing contracts to safety sign-off, depending on the product's complexity and how much documentation already exists.
Every project is scoped individually, because the work depends on the size of the product and how clinically risky it is. The first conversation is free and without obligation.
Clinical Safety Officer trained through NHS Digital's clinical safety training, with an MSc in Health Informatics and current GMC registration.
DCB0129 work for a patient-facing AI chatbot and for medical device middleware, and DCB0160 assessment of around 15 primary care products, including AI scribes, digital front doors and AI receptionists. See selected work →
Get in touch
Tell me a little about your product or deployment and where you are with it. We'll use the first, free conversation to work out what you need and how long it should take.
Thank you for getting in touch. I'll reply by email as soon as I can.
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